Traumatic Brain Injury and Effects of Acute Cyclosporine A

Withdrawn before enrolling · Phase 1/Phase 2 · Has a placebo group

Conditions studied: Traumatic Brain Injury

In brief

This is a prospective, randomized, placebo-controlled study about Cyclosporine A (CSP) and traumatic brain injury (TBI). Cyclosporine A is a drug already marketed and available for other diseases, but is not approved by the Food and Drug Administration for treatment of traumatic brain injury. The effect of Cyclosporine A on chemicals produced following brain injury is being determined using doses no larger than those used for patients having organ transplant. It is also being given for a much shorter time period (3 days). It is not know if side effects seen in patients taking cyclosporine A will occur when it is given for only 3 days. It is not known if patients with brain injury that are treated with cyclosporine A will have side effects like those seen in organ transplant patients.

Key facts

Study ID

NCT02496975

Run by

Edward Hall,PhD

People needed

0

Starts

2017-08-07

Expected to finish

2017-08-07

Last updated by the study team

2017-10-26

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participant is between the ages of 18 and 65
• Participant speaks and understands English
• CT Scan evidence of severe TBI
• Post resuscitation GSC 4-8 with at least one reactive pupil
• motor score of greater than 5
• Study medication will be administered within 8 hours injury

You may not qualify if…

• Participant received high dose systemic corticosteroids, such as Methylprednisolone >15 mg/kg or equivalent,
• Participant has a known allergy to cyclosporine A,
• Participant is pregnant,
• Participant is less than 18 years of age or greater than 65 years of
• Participant has a history of kidney problems, history of stroke or spinal cord injury,
• Participant has a history of cardiovascular disease, or use of immunosuppressive therapy in the last three months,
• Participant has a history of malignant tumors unless they have been in remission at least five years.
• Participant has an active infection
• Participant has taken part in another investigational trial within the last 30 days.

Where it is running

• University of Kentucky Medical Center — Lexington, Kentucky, United States

Full record on ClinicalTrials.gov

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